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Recall Observatory FDA recall evidence

Device product

DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF, or 2016-09EG, or Catalog No. 863, Lot No. 2016-08DC: TOTAL JOINT PACK A&B, REF 89-5720.04; PACEMAKER PACK, REF 89-6717.03

Z-0241-2016

August 31, 2015

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 72098
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0241-2016

Official wording

Reason: Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization.

Code information: REF 89-5720.04, Lot Number 38322988; REF 89-6717.03, Lot Numbers: 38323059 and 38342436

Distribution pattern: SC, FL, OH, NJ, OK, MN, AR

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization.